Dried influenza vaccine preparation and method of producing the same

Abstract

The present invention provides a dried influenza vaccine preparation in which the activity of an influenza vaccine antigen can be stably maintained even when stored without strictly maintaining a low temperature, and which can be stably supplied. The present invention also provides a method of producing the dried influenza vaccine preparation. The present invention provides a dried influenza vaccine preparation containing an influenza vaccine antigen and a disaccharide, wherein the disaccharide is at least one selected from the group consisting of sucrose, maltose, palatinose, melibiose, isomalt, cellobiose, allolactose, isomaltose, sophorose, lactobionic acid, laminaribiose, xylobiose, turanose, gentiobiose, rutinose, kojibiose, nigerose, robinose, neohesperidose, sucralose, and maltitol.

Description

TECHNICAL FIELD[0001]The present invention relates to a dried preparation containing an influenza vaccine antigen. More specifically, the present invention relates to a dried influenza vaccine preparation in which the activity of an influenza vaccine antigen can be stably maintained even when stored without: strictly maintaining a low temperature, and which can be stably supplied. The present invention also relates to a method of producing the dried influenza vaccine preparation.BACKGROUND ART[0002]Influenza is a type of acute infection caused by an influenza virus. The incubation period from infection with the influenza virus to onset of influenza is usually one to two days. The onset is accompanied by the following symptoms, for example: a fever of 38 degrees or higher, systemic symptoms (such as general malaise, headache, joint pain, and muscle pain) , sore throat, cough, and nasal discharge. In general, recovery takes one week or less. Influenza may lead to complications such as...

AI Technical Summary

Benefits of technology

The present invention provides a dried influenza vaccine preparation that can be easily distributed and stored without the need for strict temperature control. The preparation is stabilized by a low-cost disaccharide. Additionally, the preparation can be used in various forms, such as an injectable drug or a nasal spray, and can be adapted for different administration routes. The technical effects of this invention include improved stability and adaptability for various administration forms.

Problems solved by technology

Influenza may lead to complications such as pneumonia and bronchitis, which may become severe and result in death, in the case of onset of influenza in people such as elderly people, infants, pregnant women, patients with chronic respiratory disease, patients with chronic cardiovascular disease, diabetic patients, and chronic renal failure patients.

In addition, influenza intensively occurs in epidemics in a short period of time, and thus sometimes affects the society and causes an economic loss.

Although the epidemic season is different depending on the region, influenza is pandemic, and it is difficult to distribute the preparation while maintaining the activity of the influenza vaccine antigen in the countries and regions where it is difficult to maintain a low temperature.

However, while influenza virus particles have a high sterol content and are usually stable, problems such as a time-dependent decrease in the titer occur during a storage period in the case where the vaccine antigen is obtained by disrupting virus particles, removing lipid matter from the virus particles, and isolating or purifying viral proteins.

Yet, at present, no dried influenza vaccine preparation having excellent stability is commercially available, and there is a demand for further improvement in stability.

In fact, in 2011, Hayashibara Co., Ltd. filed for protection under the bankruptcy law, which endangered the supply of trehalose.